Medical Affairs in Japan

Following the previous entry, I would like to explain the Medical Affairs situation in Japan.This area isn't matured yet in Japan, though many foreign-capital pharmaceutical company so called GAISHI has been trying to expand Medical Affairs function to reach out practicing physicians. The biggest hurdle would be restriction on funding for investigator initiated study (IIS) by pharmaceutical industry. When investigators try to conduct a clinical study, they cannot have any direct support from pharmaceutical company.This restriction has been originally based on anti-trust law. Following this law, each industry has own autonomous council which is acknowledged by Fair Trade Commission (FTC). In pharmaceutical industry, it is supposed to be the Fair Trade Council of the Ethical Drug Manufacturing Industry (FTC-EDMI: http://www.iyakuhin-koutorikyo.org/). The FTC-EDMI has issued the 'Code of Fair Competition' which restricts specific funding for investigator initiated study. This code wasn't issued by regulatory authority itself, but by autonomous council acknowledged by FTC (authority). Thus, this code has been regarded as a kind of a law itself by the industry.In this way, even though many GCP studies have been conducted by pharmaceutical companies, almost none of IIS has been done as GCP study in Japan because of lack of funding. The investigators cannot have placebo supply, study drug supply, or statistical support from the pharmaceutical industry. This seems to be a factor of poor productivity of Japanese clinical study.To circumvent the restriction of direct funding to any specific study (stipulated by the said code), the pharmaceutical companies have provided many contribution under the name of scholastic promotion. But actually most of the contribution were made for specific studies. As you might realize, this contribution is legally gray. And generally, the amount of the contributions end up with relatively small price (less than $1 million at very best case), because public company cannot pay legally questionable money with big price in order to be accountable to share holders. Considering strict implementation of compliance in global company, the sustainability of this contribution has been challenged.It should be about time to change the code in Japan. But existing interested parties (pharmaceutical companies, and medical institution) are not willing to change the situation, because there are some risk for them to lose already established interests.Recently JAPhMed released a proposal to change the situation as a first step (http://japhmed.jp/whats_new/post_18.html). Though they seem to have had some negative pressure from the industry, I wish their effort produce the initial momentum for the big change.